Senior/Principal Statistical Programming

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Act as the primary statistical programmer for various studies and/or compounds.

• Lead and implement statistical programming tasks throughout clinical trials, from study initiation to database lock, reporting, and regulatory submissions.

• Ensure the consistency, quality, and timely delivery of programming outputs.

• Assist with global regulatory submissions and responses to inquiries from health authorities.

• Provide technical oversight and guidance for outsourced statistical programming efforts.

• Create, review, and validate tables, listings, figures (TLFs), SDTM/ADaM datasets, and Define-XML documentation.

• Develop, quality check/validate, and document SAS programs.

• Contribute to the establishment of SAS programming standards, SOPs, work instructions, and best practices.

• Maintain study-related programming documentation in line with Ipsen processes, ensuring it is ready for inspection/audit.

• Collaborate with statisticians, clinical teams, data management, and various cross-functional stakeholders.

• Provide technical guidance and mentorship to other statistical programmers.

• Identify opportunities for process improvements and support complex study design methodologies.

• Serve as a subject matter expert in statistical programming and contribute to technical decision-making.

⛳️ Requirements

• Strong expertise in SAS programming within a pharmaceutical, biotechnology, or CRO setting.

• In-depth understanding of CDISC standards, including SDTM and ADaM.

• Practical experience in developing and programming SDTM and ADaM specifications.

• Extensive experience in TFL programming and reporting.

• Background in supporting clinical trial reporting and/or regulatory submissions.

• Familiarity with complex clinical trial data and study designs.

• Ability to provide technical leadership and independently oversee programming activities across multiple studies.

• Over 8 years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment focused on clinical development.

• Bachelor’s or Master’s degree in Statistics, Mathematics, or a related scientific discipline.

• Proficiency in English.

• Experience in Oncology, Rare Diseases, or Neuroscience is preferred.

• Familiarity with R or other statistical packages is desirable.

• Experience in NDA/sNDA submissions is a plus.

• Proficiency in French is preferred.

🏝️ Benefits

• Job security and additional career advancement opportunities through employment with a global CRO.

• Ongoing training and professional development.

• Supportive management and training environment.

• Equal opportunity employer dedicated to diversity and inclusivity.